Cognitive and Cerebral Blood Flow Effects of Vitamin C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Kennedy, Northumbria University
ClinicalTrials.gov Identifier:
NCT01055418
First received: January 22, 2010
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

This investigation is interested in the effects of high dose vitamin C on endothelial function in healthy humans. A high fat meal will be utilized to induce endothelial dysfunction. It is hypothesized that, via antioxidant actions, vitamin C will reverse these effects and in turn improve blood flow- the involvement of nitric oxide suggests that this could extend to cerebral blood flow. This will be monitored by trans cranial doppler flow meter and near infrared spectroscopy.


Condition Intervention Phase
Endothelial Function
Cognition
Dietary Supplement: Vitamin C
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cognitive and Cerebral Blood Flow Effects of Vitamin C

Resource links provided by NLM:


Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • Endothelial function (using cerebral blood flow as a proxy measurement as measured by TCD and NIRS. [ Time Frame: ~100 mins ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive performance [ Time Frame: ~50 mins ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Dietary Supplement: Vitamin C
Vitamin C will be administered at a dose of 1000mg. There will be at least a 48 hour wash out period between both conditions (placebo and vitamin C), with the order dicteted by Latin square.
Experimental: Vitamin C Dietary Supplement: Vitamin C
Vitamin C will be administered at a dose of 1000mg. There will be at least a 48 hour wash out period between both conditions (placebo and vitamin C), with the order dicteted by Latin square.

Detailed Description:

The acute effect of administering vitamins has received little research attention. The exceptions are a number of studies that have observed that single doses of a variety of vitamins, including Vitamin C, E and several B vitamins, ameliorate endothelial dysfunction in the periphery in participants who smoke, or suffer disorders such as diabetes mellitus and cardio-vascular disease. Endothelial function also varies in healthy people as a consequence of diet, and it is possible that antioxidant vitamins can attenuate the vaso-constriction associated with commonly consumed foodstuffs. Indeed, a study by Title et al (2000) showed that vitamin C improved endothelial function in the forearm following a glucose drink. Given the putative underlying mechanisms involved (e.g. nitric oxide synthesis) any improvement may well also extend to cerebral blood flow (CBF), and therefore improvements in aspects of cognitive function.

The study will therefore assess the effects of a single dose of 1000 mg of vitamin C on cognitive performance and cerebral arterial blood flow velocity (cBFV) using Trans-cranial Doppler, following a high fat meal that has been used in previous endothelial function research.

The high fat meal will be administered 2 hours before testing begins. Research shows that a meal of this type produces effects on the endothelium which are similar to those induced by dysfunctions such as diabetes i.e. blood flow restriction. No adverse effects have been reported with regards this methodology however.

In order to monitor the effects of vitamin C (or not in the case of placebo) on endothelial function and cerebral blood flow near infrared spectroscopy (NIRS) and trans cranial Doppler (TCD) recordings will be taken throughout (in the case of the former technique) and at intermittent stages (in the case of the latter). Both neuroimaging modalities, when used correctly) are entirely safe. Blood pressure readings will also be taken intermittently throughout testing sessions.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male/Female,
  • 18-35

Exclusion Criteria:

  • Smokers,
  • not proficient in English,
  • are (or are seeking to become) pregnant, are currently taking illicit,
  • over the counter/prescription medication (including the contraceptive pill),
  • and/or dietary/herbal supplements.
  • Food allergies or sensitivities that are relevant to the study,
  • a history of/current head trauma,
  • learning difficulties,
  • ADHD and
  • migraines.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055418

Locations
United Kingdom
Brain, Performance and Nutrition Research Centre, Northumbria University
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Investigators
Study Director: David Kennedy Northumbria University
  More Information

No publications provided

Responsible Party: David Kennedy, Professor, Northumbria University
ClinicalTrials.gov Identifier: NCT01055418     History of Changes
Other Study ID Numbers: 24AD1
Study First Received: January 22, 2010
Last Updated: May 1, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Northumbria University:
Vitamin C
Cognitive performance
Cerebral blood flow
Trans cranial doppler
Near infrared spectroscopy

Additional relevant MeSH terms:
Ascorbic Acid
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 21, 2014